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Rozerem

"Sleep disorder drugs (hypnotic and sedative drugs) overview

Insomnia, a disorder in which there is difficulty sleeping, occurs occasionally in most people but usually lasts only a few days. The body then "corrects" itself "...

Rozerem

Rozerem

Rozerem Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rozerem (ramelteon) is used to treat insomnia that is associated with having trouble falling asleep. Unlike some other sleep medications, Rozerem is not known to be habit-forming. It is a hypnotic type sedative. Common side effects include dizziness, tiredness, or daytime drowsiness.

The recommended dose of Rozerem is 8 mg taken within 30 minutes of going to bed. Rozerem may interact with primaquine, thabendazole, rifampin, antibiotics, heart rhythm medications, or antifungal medications. Tell your doctor all medications you are taking. Rozerem should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

Our Rozerem (ramelteon) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Rozerem in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ramelteon and call your doctor at once if you have a serious side effect such as:

  • unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;
  • a missed menstrual period;
  • nipple discharge; or
  • loss of interest in sex.

Less serious side effects may include:

  • drowsiness, tired feeling;
  • dizziness;
  • nausea; or
  • worsening sleep problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rozerem (Ramelteon) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Rozerem Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, tiredness, or daytime drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people who take sleep medications have reported getting out of bed and sleep-walking, driving, eating, talking on the phone, or doing other activities while not fully awake. Often, they have no memory of these activities. This problem can be dangerous to you or others. If you have or think you have this problem, tell your doctor immediately. Your risk is increased if you use alcohol or other medications that can make you drowsy.

Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sexual desire, missed menstrual periods, nipple discharge, difficulty becoming pregnant.

Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes (e.g., depression, strange thoughts, thoughts of suicide).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Rozerem (Ramelteon)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rozerem FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections:

  • Severe anaphylactic and anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
  • Abnormal thinking, behavior changes, and complex behaviors [see WARNINGS AND PRECAUTIONS]
  • CNS effects [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Adverse Reactions Resulting in Discontinuation of Treatment

The data described in this section reflect exposure to ROZEREM (ramelteon) in 5373 subjects, including 722 exposed for 6 months or longer, and 448 subjects for one year.

Six percent of the 5373 individual subjects exposed to ROZEREM (ramelteon) in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 2279 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving ROZEREM (ramelteon) were somnolence, dizziness, nausea, fatigue, headache, and insomnia; all of which occurred in 1% of the patients or less.

ROZEREM (ramelteon) Most Commonly Observed Adverse Events

Table 1 displays the incidence of adverse events reported by the 2861 patients with chronic insomnia who participated in placebo-controlled trials of ROZEREM (ramelteon) .

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of other drugs, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Table 1: Incidence (% of subjects) of Treatment-Emergent Adverse Events

MedDRA Preferred Term Placebo
(n=1456)
Ramelteon 8 mg
(n=1405)
Somnolence 2% 3%
Fatigue 2% 3%
Dizziness 3% 4%
Nausea 2% 3%
Insomnia exacerbated 2% 3%

Read the entire FDA prescribing information for Rozerem (Ramelteon) »

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Rozerem - User Reviews

Rozerem User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Rozerem sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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